Tag Archives: cGMP

cGMPs – An Explanation

GoodManufacturingSusan Brown Health and Wellness Editor

Professional Supplement Center offers many high quality dietary supplement brands that manufacture their products in accordance with current Good Manufacturing Practices (cGMPs). For our customers this means they can have confidence that these dietary supplements have been manufactured to ensure identity, purity, strength, and composition, as well as accurate label claims. Dietary supplement manufacturing guidelines are intended to ensure a quality finished product by establishing a comprehensive system of procedural controls. These formal procedures, established and enforced by the US Food and Drug Administration (FDA), not only assure the proper design, monitoring, and control of manufacturing facilities, but also provide for thorough documentation at each stage of the manufacturing process.

Authorized by the Dietary Supplements Health and Education Act (DSHEA), these uniform practices are the gold standard employed throughout every step in manufacturing, packaging, labeling and storing of dietary supplements. Supplement manufacturers who conform to FDA unified standards also establish strong quality management systems and operating procedures, obtain appropriate quality raw materials, detect and investigate product quality deviations, and maintain reliable testing laboratories. Dietary supplement marketing, manufacturing, labeling, and advertising are all covered by regulations enforced by FDA and the Federal Trade Commission.

Dietary supplements in the form of tablets, capsules, soft gels, gel caps, liquids or powders are regulated products simply defined by DSHEA as “a product taken orally that contains a dietary ingredient intended to supplement the daily diet.” As such, the FDA regulates the types of ingredients allowed in supplements. These ingredients include vitamins, minerals, herbs, botanicals, amino acids; and other substances such as enzymes, extracts, probiotics, or concentrates. FDA also has detailed requirements for the labeling of dietary supplements, including nutrition facts, allergen statement, identity verification, and net quantity validation, among others.

A dietary supplement manufacturer must ensure that the Supplement Facts label and ingredient list for each product is accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label up until the expiration date. As some bioactive ingredients in dietary supplements, such as vitamins, can naturally lose activity and or potency over time, dietary supplement manufacturers may increase the amount of the ingredient at the time of manufacturing to maintain compliance and high quality standards. Process controls for dietary supplement manufacture include establishing and meeting specifications to verify that the finished dietary supplement contains the correct ingredient, purity, strength, and composition intended in accordance with established specifications.

Established specifications assure that the characteristics or attributes desired in the final product will be consistently, uniformly, and reliably achieved. With effective process control, quality is built into the product throughout the entire production process, including testing to preclude the presence of any compounds that may otherwise adulterate the product. Manufacturing facilities are inspected by highly trained FDA staff to attain full compliance with cGMP regulations. To ensure quality products, many industry leaders have established their own supplementary manufacturing standards, exceeding those required by cGMPs. These can include licensing as a pharmaceutical manufacturing facility, additional testing of raw materials and finished products, establishing allergen-free facilities and obtaining additional certifications, such as Quality Assurance International Organic, Non-GMO Product Verified, and NSF Certified for Sport certifications.

The word “current” signifies continual improvement; it testifies that companies employ up-to-date technology and systems to provide flexibility toward innovation and modernization for higher quality. In addition, many quality suppliers who are leaders in nutritional research and product development work closely with healthcare professionals to provide effective nutritional solutions. They are dedicated to providing science-based supplements of superior quality and integrity with the highest degree of safety. Our top-of-the-line manufacturers are committed to supporting and improving health, and are recognized for their excellence in purity, consistency, legitimacy and quality in manufacturing.

References:
Dietary Supplements Guidance Documents & Regulatory Information. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/default.htm
Facts About the Current Good Manufacturing Practices (CGMPs). https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. https://www.federalregister.gov/documents/2007/06/25/07-3039/current-good-manufacturing-practice-in-manufacturing-packaging-labeling-or-holding-operations-for
Dietary Supplements GMP Registration. http://www.nsf.org/services/by-industry/nutritional-products/dietary-supplements-gmp-registration
FAQs About Dietary Supplements Regulations. https://www.chpa.org/FAQsDS.aspx
Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling. https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm070597.htm

 

Featured Brand – Vital Nutrients

Vital_NutrientsSusan Brown Health and Wellness Editor

 

 

Vital Nutrients has a clear mission to promote good health by maintaining exceptionally high standards of quality assurance in the development and manufacture of their pharmaceutical grade, professional strength supplements. Their science-based, clinically effective, superior quality nutraceuticals provide the most synergistic and beneficial active ingredients to promote increased good health, wellbeing and vitality. Vital Nutrients takes pride in exceeding all pharmaceutical and government standards in the manufacture of their natural, research-based products designed for optimal product integrity and consistent clinical results.

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Raw materials are quarantined until independently tested for herbicides, pesticides, fungicides, heavy metals, dioxins, microorganisms, GMO’s and chemical residues. Products are manufactured in an energy efficient, FDA inspected cGMP facility without the use of binders, excipients or potential allergens. All finished products are tested for identity, authenticity, purity, potency, stability and expiration date validation. Because good health is “vital,” Vital Nutrients believes that nothing is more important than the quality of their supplements. Their efficacious products are available solely through healthcare professionals.

Based on customer reviews, here are some of our customers’ favorite products from Vital Nutrients:

BCQ by Vital NutrientsBCQ – This popular highly recommended product contains a powerful herbal combination blend that provides enhanced support for maintaining a healthy inflammatory response while reducing minor pain. Free of binders, gluten, yeast, dairy, sugar, soy and artificial ingredients.

 

Vitamin D3 2000 I.U. by Vital NutrientsVitamin D3 2000 IU – One capsule provides 2000 IU of bioavailable vitamin D3 as cholecalciferol in support of calcium absorption, bone health, colon health and the maintenance of healthy serum calcium levels. Vegetarian formulation. Free of binders, gluten, yeast, dairy, sugar and artificial ingredients.

 

Aller-C Quercetin & Bioflavonoids by Vital NutrientsAller-C Quercetin & Bioflavonoids – This potent and effective combination formula provides support for maintaining proper levels of enzymes and physiological factors needed for normal sinus and respiratory function. Free of binders, gluten, yeast, dairy, sugar, soy and artificial ingredients.

 

Triple Mag 250 mg by Vital NutrientsTriple Mag 250 mg – This 5 star-rated product supplies 3 forms of magnesium in support of numerous bodily functions, including nutrient metabolism, muscle function, healthy teeth and bone density maintenance. Free of binders, gluten, yeast, dairy, sugar, soy and artificial ingredients.

 

A Word About Current Good Manufacturing Practices (cGMPs)

cGMPSusan Brown Health and Wellness Editor

 

 

Many of the high quality product lines we carry at Professional Supplement Center follow dietary supplement Current Good Manufacturing Processes, commonly called cGMPs. These rigorous manufacturing rules and processes are the main regulatory standards enforced by the U.S. Food and Drug Administration (FDA) to ensure quality, safety and efficacy in manufacturing. Nutraceutical and quality supplement providers that adhere to cGMPs guidelines follow stringent regulations, similar to pharmaceutical and food manufacturing standards.  

By requiring manufacturers to adequately control all manufacturing operations, adherence to cGMPs regulations assures the identity, strength, composition and purity of all products. Compliance to these regulations means a company has established strong quality management systems, obtains appropriate quality raw materials, has sound operating procedures, maintains reliable testing laboratories and adheres to packaging and labeling standards. The cGMPs help to ensure that manufacturers consistently produce unadulterated and properly labeled dietary supplements.

Manufacturing facilities are inspected by highly trained FDA staff to ensure full compliance with cGMP regulations. To ensure quality products, many industry leaders have established their own supplementary manufacturing standards, exceeding those required by cGMPs. These can include licensing as a pharmaceutical manufacturing facility, additional testing of raw materials and finished products, establishing allergen-free facilities and obtaining additional certifications, such as Quality Assurance International Organic and Non-GMO Product Verified certifications.  

The word “current” is included to ensure companies use technology and systems that are up-to-date and allows companies the flexibility to innovate and modernize to achieve higher quality through continual improvement. Adherence to cGMPs ensures supplements meet quality standards, are free from contamination and are adequately labeled. For our customers this means they can have confidence that these dietary supplements have been manufactured to ensure identity, purity, strength, composition and accurate label claims.

In addition, our quality suppliers work closely with healthcare professionals to provide effective nutritional solutions and are leaders in nutritional research, product development and innovation. They are dedicated to providing science-based supplements of superior quality and integrity with the highest degree of safety. Our top-of-the-line manufacturers are committed to improving health and are recognized for their excellence in purity, consistency, legitimacy and quality in manufacturing.

References:
Facts About the Current Good Manufacturing Practices (CGMPS). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
Dietary Supplement Current Good Manufacturing Practices (CGMPs). http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm
Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Hold Operations for Dietary Supplements; Small Entity Compliance Guide. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation